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Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

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Contents

clinicaltrials.gov/study/NCT01993940
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT019939400
Trial Recruitment Size
5530
Trial Sponsor
Shionogi
Shionogi
0
Clinical Trial Start Date
November 4, 2013
0
Primary Completion Date
June 9, 2015
0
Study Completion Date
June 9, 2015
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
Naldemedine0
Placebo0
Interventional Trial Phase
Phase 30
Official Name
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy0
Last Updated
May 30, 2017
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Investigator0
Care Provider0
Participant0
Outcomes Assessor0
Study summary

The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.

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